Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059839
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2003-05-06
Brief Title:
Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma ALCL With Standard APO Doxorubicin Prednisone Vincristine Versus Consolidation With a Regimen Including Vinblastine
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma
Detailed Description:
OBJECTIVES
Compare the efficacy of a consolidation chemotherapy regimen comprising doxorubicin and prednisone in combination with vincristine vs vinblastine in terms of event-free survival in patients with advanced anaplastic large cell lymphoma
Compare overall survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Correlate biological tumor characteristics and outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study
Patients are randomized at enrollment to receive either Standard APO regimen or a consolidation regimen including vinblastine VBL
Induction therapy All Patients receive doxorubicin IV over 15 minutes on days 1 and 22 vincristine IV on days 1 8 15 22 and 29 oral prednisone 3 times daily on days 1-28 and intrathecal IT methotrexate on days 1 8 and 22 patients with central nervous system CNS disease at diagnosis receive additional methotrexate IT on days 15 29 and 36
Patients undergo restaging after Induction such that consolidation therapy is started on day 43 All patients with complete response CR complete response unconfirmed CRu or partial response PR proceed to Consolidation based on CT or MRI scans at the end of induction week 6 All other patients will be removed from protocol therapy and will be followed until they meet the criteria for off study Follow-up data will be required unless consent is withdrawn
Standard APO Arm I Patients receive course-specific regimens without vinblastine
Courses 1-3 Patients receive doxorubicin IV over 15 minutes vincristine IV and methotrexate IT on day 1 and oral prednisone three times daily and oral mercaptopurine once daily on days 1-5
Courses 4-5 Patients receive doxorubicin vincristine prednisone and mercaptopurine as in courses 1-3
Courses 6-15 Patients receive vincristine prednisone and mercaptopurine as in courses 1-3 and methotrexate IV on day 1
Consolidation with vinblastine Arm II Patients receive course-specific regimens including vinblastine
Courses 1-3 Patients receive doxorubicin methotrexate IT prednisone and mercaptopurine as in arm I and vinblastine IV over 1 minute on days 1 8 and 15
Courses 4-5 Patients receive doxorubicin prednisone and mercaptopurine as in arm I and vinblastine as in arm II courses 1-3
Courses 6-15 Patients receive prednisone and mercaptopurine as in arm I vinblastine as in arm II courses 1-3 and methotrexate IV on day 1
In both arms and all courses treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 1 year every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 200-250 patients 100-125 per treatment arm will be accrued for this study within 5 years
Compare the efficacy of a consolidation chemotherapy regimen comprising doxorubicin and prednisone in combination with vincristine vs vinblastine in terms of event-free survival in patients with advanced anaplastic large cell lymphoma
Compare overall survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Correlate biological tumor characteristics and outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study
Patients are randomized at enrollment to receive either Standard APO regimen or a consolidation regimen including vinblastine VBL
Induction therapy All Patients receive doxorubicin IV over 15 minutes on days 1 and 22 vincristine IV on days 1 8 15 22 and 29 oral prednisone 3 times daily on days 1-28 and intrathecal IT methotrexate on days 1 8 and 22 patients with central nervous system CNS disease at diagnosis receive additional methotrexate IT on days 15 29 and 36
Patients undergo restaging after Induction such that consolidation therapy is started on day 43 All patients with complete response CR complete response unconfirmed CRu or partial response PR proceed to Consolidation based on CT or MRI scans at the end of induction week 6 All other patients will be removed from protocol therapy and will be followed until they meet the criteria for off study Follow-up data will be required unless consent is withdrawn
Standard APO Arm I Patients receive course-specific regimens without vinblastine
Courses 1-3 Patients receive doxorubicin IV over 15 minutes vincristine IV and methotrexate IT on day 1 and oral prednisone three times daily and oral mercaptopurine once daily on days 1-5
Courses 4-5 Patients receive doxorubicin vincristine prednisone and mercaptopurine as in courses 1-3
Courses 6-15 Patients receive vincristine prednisone and mercaptopurine as in courses 1-3 and methotrexate IV on day 1
Consolidation with vinblastine Arm II Patients receive course-specific regimens including vinblastine
Courses 1-3 Patients receive doxorubicin methotrexate IT prednisone and mercaptopurine as in arm I and vinblastine IV over 1 minute on days 1 8 and 15
Courses 4-5 Patients receive doxorubicin prednisone and mercaptopurine as in arm I and vinblastine as in arm II courses 1-3
Courses 6-15 Patients receive prednisone and mercaptopurine as in arm I vinblastine as in arm II courses 1-3 and methotrexate IV on day 1
In both arms and all courses treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 1 year every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 200-250 patients 100-125 per treatment arm will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COG-ANHL0131 | OTHER | Childrens Oncology Group | None |
| CDR0000298777 | OTHER | None | None |